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NCT Number: NCT06415760

Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy

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Key information

Conditions

Obstetric Hemostasis Cardiovascular Diseases Coagulation Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Florida Medicine, Gainesville, Florida, United States

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About this study

During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is female, age 18 to 45 years old.
  • Subject is pregnant with a single fetus and duration of pregnancy is >28weeks
  • Subject is willing to participate and has provided informed consent.

Exclusion criteria

  • Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies).
  • Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants.
  • Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor.
  • Subject had a blood transfusion during pregnancy.
  • Subject has a history of smoking/vaping during pregnancy

Treatment and study plan

Quantra System

Diagnostic Test

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Other names: QStat Cartridge

Primary outcomes

  1. Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for CSL for pregnant women in third trimester

  2. Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for FCS for pregnant women in third trimester

  3. Reference range intervals for measurement of Platelet Contribution (PCS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for PCS for pregnant women in third trimester

  4. Reference range intervals for measurement of Clot Stiffness (CS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for CS for pregnant women in third trimester

  5. Reference range intervals for measurement of Clot Time (CT) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for CT for pregnant women in third trimester

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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